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Defitelio(defibrotide)
Defitelio (defibrotide) is an oligonucleotide pharmaceutical. Defibrotide was first approved as Defitelio on 2013-10-18. It is used to treat hepatic veno-occlusive disease in the USA. It has been approved in Europe to treat hepatic veno-occlusive disease.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Defitelio
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Defibrotide sodium
Tradename
Company
Number
Date
Products
DEFITELIOJazz PharmaceuticalsN-208114 RX2016-03-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
defitelioNew Drug Application2016-03-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatic veno-occlusive disease—D006504K76.5
Agency Specific
FDA
EMA
Expiration
Code
DEFIBROTIDE SODIUM, DEFITELIO, JAZZ PHARMS INC
2023-03-30ODE-112
Patent Expiration
Patent
Expires
Flag
FDA Information
Defibrotide Sodium, Defitelio, Jazz Pharms Inc
110850432032-06-22DP
112363282032-06-22U-3301
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AX: Other antithrombotic agents in atc
— B01AX01: Defibrotide
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndotoxemiaD019446———1—1
Healthy volunteers/patients————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic veno-occlusive diseaseD006504K76.5—34—17
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.113———4
Sickle cell anemiaD000755EFO_0000697D57—2———2
Neurotoxicity syndromesD020258G92—1———1
Multiple myelomaD009101C90.011———1
Mucocutaneous lymph node syndromeD009080EFO_0004246M30.3—1———1
Acute chest syndromeD056586EFO_0007129—1———1
Thrombotic microangiopathiesD057049M31.1—1———1
Graft vs host diseaseD006086D89.81—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J801————1
Severe acute respiratory syndrome-related coronavirusD045473NCBITaxon_2278591————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107EFO_0001421K70-K77————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDEFIBROTIDE
INNdefibrotide
Description
Defibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs. It is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant, with different limitations in the US and the European Union. It works by protecting the cells lining blood vessels in the liver and preventing blood clotting; the way it does this is not well understood.
Classification
Oligonucleotide
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID83712-60-1
RxCUI1311089
ChEMBL IDCHEMBL2108396
ChEBI ID—
PubChem CID135565962
DrugBankDB04932
UNII IDL7CHH2B2J0 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Defitelio - Jazz Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,003 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,085 adverse events reported
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